EU Clinical Trials Register Goes Live
The EU Clinical Trials Register was launched by the European Medicines Agency (EMA). The online register gives for the first time public access to information on interventional clinical trials for medicines authorised in the 27 EU Member States and Iceland, Liechtenstein and Norway. The database also allows the public to search for information on clinical trials authorised to be carried out outside the EU if these trials are part of a paediatric investigation plan.
The information contained in the EU Clinical Trials Register is extracted from EudraCT, the EU clinical trials database. It is provided by the sponsor of the clinical trial, and is a component of its application to a national medicines regulatory authority for authorisation to conduct a trial. The information from the sponsor is loaded into the EudraCT database by the national medicines regulatory authority. The authority adds to this information the authorisation of the clinical trial and the opinion from the relevant ethics committee. Information on third-country trials that are listed in a paediatric investigation plan (PIP) is provided by the PIP addressee directly, via the EMA, to the system.
Throughout the project the Agency worked together with stakeholders, including patients and healthcare professionals, to ensure that their needs were taken into account, to the extent possible at this stage, when designing the register.
The Agency will continue to work with stakeholders to improve the functioning of the EU Clinical Trials Register, in particular by enhancing the quality and completeness of data, and improving the search functionality. Plans for the future also include the publication of summaries of clinical trial results, on which draft guidance has already been published for consultation by the European Commission. Publication of trial results summaries will require a major upgrade to the existing system, the start of which will depend on finalisation of the guideline and availability of budget and resources.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.
